Effect of Electroacupuncture on Mixed Urinary Incontinence Among Women
NCT ID: NCT04531683
Last Updated: 2020-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
460 participants
INTERVENTIONAL
2020-10-30
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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electroacupuncture
patients will receive electroacupuncture at 3 acupoints (Bladder meridian of foot-taiyang 33 and 35（BL33 and BL35), and Spleen meridian of foot-taiyin 33(SP6)) 3 times/week for 8 weeks(24 times in total), followed with 24-weeks follow up. Disposable acupuncture needles with size of 0.30 × 75 mm will be used at BL 33 and BL 35, and needles with size of 0.30 × 40 mm at SP 6. Standardised electroacupuncture apparatuses will be used, and the stimulation will last for 30 minutes with a continuous wave of 20 Hz, and a current intensity of 2 to 6.5 mA at BL33 and BL 35, and 1 to 3.5 mA at SP6. Life style counselling will be provided to all patients and contents are as same as the life style counselling group.
electroacupuncture
same as described in experimental arm.
life style counselling
life style counselling to patients with mixed urinary incontinence contains advice on daily drinking, caffeine intake, diet, constipation, exercise, heavy lifting, lung disease, urinary track infection and etc.
sham electroacupuncture
patient will receive sham electroacupuncture with the same frequency and amount as applied in the electroacupuncture group, as well as the follow-up period. Disposable acupuncture needles with size of 0.30 × 40 mm will be applied and penetrate the skin of patients for 2 to 3mm at sham acupoints to the 3 acupoints mentioned above. The stimulation will only last for 30-second with a very weak currency intensity and a continuous wave of 20 Hz. Life style counselling will be provided to all patients and contents are as same as the life style counselling group.
sham electroacupuncture
same as described in sham comparator.
life style counselling
life style counselling to patients with mixed urinary incontinence contains advice on daily drinking, caffeine intake, diet, constipation, exercise, heavy lifting, lung disease, urinary track infection and etc.
life style counselling group
patients randomised to this group will receive a one-time life style counselling at the enrolment to improve their daily behaviour to expedite the recovery of their mixed urinary incontinence. Then the patients will be followed up for 20 weeks.
life style counselling
life style counselling to patients with mixed urinary incontinence contains advice on daily drinking, caffeine intake, diet, constipation, exercise, heavy lifting, lung disease, urinary track infection and etc.
Interventions
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electroacupuncture
same as described in experimental arm.
sham electroacupuncture
same as described in sham comparator.
life style counselling
life style counselling to patients with mixed urinary incontinence contains advice on daily drinking, caffeine intake, diet, constipation, exercise, heavy lifting, lung disease, urinary track infection and etc.
Eligibility Criteria
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Inclusion Criteria
2. Patients are between age of 35 to 75 years old;
3. Positive in cough stress test;
4. Experience persistent urinary incontinence for at least 3 months, and at least one episode for each of stress and urgent urinary incontinence in 72 hours in baseline screening; and
5. Patients have signed informed consent form and are willing to participate the study voluntarily.
Patients will be included if all above 5 items are met.
Exclusion Criteria
2. Patients have uncontrolled urinary tract infection with urinary pain and urge;
3. Patients have urogenital system tumours and/or pelvic organ tumours;
4. Patients have taken drugs for urinary incontinence treatment or drugs possibly affect the function of lower urinary tract, or received non-drug treatment for urinary incontinence (i.e. electrical stimulation, bladder training, pelvic floor muscle training, and etc.) in the past one month;
5. Patients have history of surgeries for urinary incontinence and/or pelvic floor organs, including hysterectomy;
6. Patients have pelvic organ prolapse ≥ II degree;
7. Patients have residual urine ≥ 100ml;
8. Patients have uncontrolled diabetes mellitus and severe hypertension;
9. Patients have diseases affecting lower urinary tract function, e.g. multiple sclerosis, Alzheimer's disease, Parkinson's disease, spinal cord injury, cauda equina injury and multiple system atrophy, etc.;
10. Patients have severe heart, lung, brain, liver, kidney and hematopoietic system diseases, mental disorders and cognitive dysfunction;
11. Patients are constrained or unable to complete movements like walking, going stairs up and down and running, etc.;
12. Patients have poor compliance;
13. Patients are at pregnancy, breastfeeding or postpartum period for less than 12 months;
14. Patients have cardiac pacemaker, metal allergy or strong fear of needle;
15. Patients are participants of other on-going studies; or
16. Patients have received acupuncture in the past 3 months. Patients will be excluded if they meet any of the above criteria.
35 Years
75 Years
FEMALE
No
Sponsors
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Shaanxi Hospital of Traditional Chinese Medicine
OTHER
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
OTHER
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
OTHER
Hubei Hospital of Traditional Chinese Medicine
OTHER
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
OTHER
Shanghai University of Traditional Chinese Medicine
OTHER
Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
OTHER
Guangdong Provincial Hospital of Traditional Chinese Medicine
OTHER
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Liu Zhishun
Chief Physician, Dean of Acupuncture Department
Principal Investigators
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Zhishun Liu, PhD
Role: PRINCIPAL_INVESTIGATOR
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Central Contacts
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Other Identifiers
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ZZ13-024-9
Identifier Type: -
Identifier Source: org_study_id
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